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Evaluation study of a treatement with Nivolumab and Ipilimumab or tKi according to molecular group in naïve metastatic Kidney cancer
EU CTIS ID: 2024-520045-23-00
What this study is testing
To evaluate the ORR according to molecular subgroups (ccRCC1 to 4)and assigned treatment (nivolumab monotherapy, nivolumab combined with ipilimumab, or TKI: sunitinib or pazopanib), based on Investigator assessments.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histological confirmation of RCC with a clear-cell component. Patients with TFE3 or TFEB translocation proven by cytogenetic analysis or by fluorescence in situ hybridization (FISH) are eligible.
- Metastatic (American Joint Committee on Cancer [AJCC] Stage IV) RCC
- No prior systemic therapy for mRCC (patients with relapse >1 year after adjuvant treatment discontinuation are eligible)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2
- Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Frozen tumor samples or fresh tumor samples immediately stored in "RNA later" medium (primary tumor and/or metastasis biopsies) must be available and received by the central laboratory (Cordelier Research Center) to determine molecular groups. (Note: fine needle aspiration [FNA] and bone metastases samples are not acceptable for submission).
You likely can't join if
- Any untreated CNS metastases. Patients with CNS metastases will be eligible if they are: asymptomatic, without significant edema, not on corticosteroids, not eligible for radiation therapy/surgery or have already received radiation therapy.
- History of cerebrovascular accident including transient ischemic attack within the past 12 months.
- History of DVT unless adequately treated with low molecular weight heparin
- History of pulmonary embolism within the past 6m unless stable, asymptomatic, and treated with low molecular weight heparin for at least 6 weeks
- Known history of COPD
- Known history of uveitis or complaint of double vision
See the full eligibility criteria
Who can join
- Histological confirmation of RCC with a clear-cell component. Patients with TFE3 or TFEB translocation proven by cytogenetic analysis or by fluorescence in situ hybridization (FISH) are eligible.
- Metastatic (American Joint Committee on Cancer [AJCC] Stage IV) RCC
- No prior systemic therapy for mRCC (patients with relapse >1 year after adjuvant treatment discontinuation are eligible)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2
- Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Frozen tumor samples or fresh tumor samples immediately stored in "RNA later" medium (primary tumor and/or metastasis biopsies) must be available and received by the central laboratory (Cordelier Research Center) to determine molecular groups. (Note: fine needle aspiration [FNA] and bone metastases samples are not acceptable for submission).
- Formalin-fixed, paraffin-embedded (FFPE) tumor tissue available for biomarker (gene expression and immunohistochemistry (IHC)) analysis
- Molecular group has to be determined prior to randomization.
What rules you out
- Any untreated CNS metastases. Patients with CNS metastases will be eligible if they are: asymptomatic, without significant edema, not on corticosteroids, not eligible for radiation therapy/surgery or have already received radiation therapy.
- History of cerebrovascular accident including transient ischemic attack within the past 12 months.
- History of DVT unless adequately treated with low molecular weight heparin
- History of pulmonary embolism within the past 6m unless stable, asymptomatic, and treated with low molecular weight heparin for at least 6 weeks
- Known history of COPD
- Known history of uveitis or complaint of double vision
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months.
- Serious, non-healing wound or ulcer
- Evidence of active bleeding or bleeding susceptibility; or medically significant hemorrhage within prior 30 days.
- Any requirement for anti-coagulation, except for low molecular weight heparin
- Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
- Prior systemic treatment with VEGF or VEGF receptor-targeted therapy (including, but not limited to, sunitinib, pazopanib, axitinib, tivozanib, and bevacizumab) except in an adjuvant setting with a free interval of more than 1 year.
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection.
- Known medical condition (e.g., a condition associated with diarrhea or acute diverticulitis) that, in the Investigator’s opinion, would increase the risk associated with study participation or study drug administration, or interfere with the interpretation of safety results
- Known history of hyperesthesia, hypoesthesia, paresthesia, dysesthesia, peripheral motor neuropathy, peripheral sensory, neuropathy, and polyneuropathy
- Major surgery (e.g., nephrectomy) less than 35 days prior to the first dose of study drug
- Focal radiation therapy less than 14 days prior to the first dose of study drug.
- Receiving concomitant CYP3A4 inducers or strong CYP3A4 inhibitors
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of TKI (e.g., malabsorptive disorder, ulcerative disease, uncontrolled nausea, vomiting, diarrhea, or small bowel resection).
- Any of the following laboratory test findings: a) WBC <2,000/mm3 b) Hemoglobin ≤9.0 g/dL c) Neutrophils <1,500/mm3 d) Platelets <100,000/mm3 e) AST or ALT >3 x ULN (>5 x ULN if liver metastases are present) f) Lipase and amylase > 1.5 ULN g) Total Bilirubin >1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin <3.0 mg/dL) h) Serum creatinine >1.5 x ULN or creatinine clearance <40 mL/min (measured or calculated by Cockroft-Gault formula) i) Proteinuria: patients with ≥2+ protein on urine dipstick at baseline must undergo a 24-hour urine collection for protein then if > 1.0 g of protein patient will not be included.
- Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (>10 mg daily prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger. Subjects with vitiligo or type 1 diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll.
- Any condition requiring systemic treatment with corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of SD. Inhaled steroids and adrenal replacement steroid doses >10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- Uncontrolled adrenal insufficiency
- Ongoing symptomatic cardiac dysrhythmias, uncontrolled atrial fibrillation, or prolongation of the Fridericia corrected QT (QTcF) interval defined as >450 msec for males and >470 msec for females, where QTcF = QT / 3√RR.
- Poorly controlled hypertension (defined as SBP of >150 mmHg or DBP of >90 mmHg), despite antihypertensive therapy
- History of any of the following CV conditions within 12m of enrollment: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery by-pass graft surgery, symptomatic peripheral vascular disease, class III or IV congestive heart failure, as defined by the NYHA.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.